Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations

Phase 4

Completed

• Conditions: Cognitive Impairment
• Interventions: Drug: Propofol, midazolam, fentanyl

• Registration Number: NCT00446420
• Lead Sponsor: Melbourne Health

Brief Summary

Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.

200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

Detailed Description

A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation

Exclusion Criteria

• No cognitive impairment
• Adequate English language comprehension
• Not combined with other procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Propofol, midazolam, fentanyl	These patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs
2	Propofol, midazolam, fentanyl	These patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.

Primary Outcome Measures

Name	Time	Method
Cognitive impairment at hospital discharge after elective outpatient colonoscopy	Before discharge from daycare facility

Secondary Outcome Measures

Name	Time	Method
Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care	Before discharge from daycare facility

Trial Locations

Locations (1)

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia